Trial Outcomes & Findings for The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2) (NCT NCT05845567)
NCT ID: NCT05845567
Last Updated: 2024-08-16
Results Overview
Maximum observed plasma concentration (Cmax) of givinostat. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
In the turn of 72 hours after administration of Givinostat
Results posted on
2024-08-16
Participant Flow
20 patients were enrolled. One discontinued after first dosing, so while safety and PK analysis populations were composed of 20 subjects, the drug-drug interaction comparable bioavailability is calculated on 19 subjects.
Participant milestones
| Measure |
Total Subjects Enrolled
At Day 1 patients received Givinostat 50 mg. At Days 4-7 patients received Clarithromycin 500 mg b.i.d. At Day 8 patients received Givinostat 50 mg + Clarithromycin 500 mg b.i.d At Days 9-10 patients received Clarithromycin 500 mg b.i.d.
Givinostat: ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
Clarithromycin: Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) administered twice a day, in the morning and in the evening.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
Safety Analysis Population
|
20
|
|
Overall Study
PK Analysis Population
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20
|
|
Overall Study
Drug-Drug Interaction Comparable Bioavailability
|
19
|
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Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Total Subjects Enrolled
At Day 1 patients received Givinostat 50 mg. At Days 4-7 patients received Clarithromycin 500 mg b.i.d. At Day 8 patients received Givinostat 50 mg + Clarithromycin 500 mg b.i.d At Days 9-10 patients received Clarithromycin 500 mg b.i.d.
Givinostat: ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
Clarithromycin: Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) administered twice a day, in the morning and in the evening.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
Baseline characteristics by cohort
| Measure |
Total Subjects Enrolled
n=20 Participants
At Day 1 patients received Givinostat 50 mg. At Days 4-7 patients received Clarithromycin 500 mg b.i.d. At Day 8 patients received Givinostat 50 mg + Clarithromycin 500 mg b.i.d At Days 9-10 patients received Clarithromycin 500 mg b.i.d.
Givinostat: ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
Clarithromycin: Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) administered twice a day, in the morning and in the evening.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
Portugal
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20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in the combo arm are n=19 and not n=20
Maximum observed plasma concentration (Cmax) of givinostat. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=20 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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Cmax of Givinostat, Following Single Doses of the Parent Drug
|
53.57 ng/mL
Geometric Coefficient of Variation 24.2
|
75.35 ng/mL
Geometric Coefficient of Variation 21.9
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—
|
PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in each arm are n=19 and not n=20
AUC0-t = area under the curve from time zero to last sampling time with quantifiable concentrations. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of Givinostat, on Days 1 and 8, for the determination of Givinostat.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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AUC0-t of Givinostat, Following Single Doses of the Parent Drug
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344.67 ng.h/mL
Geometric Coefficient of Variation 20.4
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406.61 ng.h/mL
Geometric Coefficient of Variation 13.0
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—
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PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in each arm are n=19 and not n=20
AUC0-inf=Total AUC extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable concentration and λz is the apparent terminal elimination rate constant. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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AUC0-inf of Givinostat, Following Single Doses of the Parent Drug
|
349.25 ng.h/mL
Geometric Coefficient of Variation 20.1
|
411.69 ng.h/mL
Geometric Coefficient of Variation 12.7
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—
|
PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in each arm are n=19 and not n=20
%AUC0extrap = Percentage of AUC0-∞ due to extrapolation from the time of the last measurable concentration (tlast) to infinity, i.e., residual area, calculated as 100 ·(AUC0-∞ - AUC0-t) / AUC0-∞. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
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Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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%AUCextrap of Givinostat, Following Single Doses of the Parent Drug
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1.28 percentage of AUC0-∞
Geometric Coefficient of Variation 23.3
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1.17 percentage of AUC0-∞
Geometric Coefficient of Variation 29.7
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—
|
PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that in the combo arm, one of the 20 PK subjects early withdrew from the study before taking the drug combination. This explains why patients analyzed in the combo arm are n=19 and not n=20.
Tmax =The time of occurrence of maximum observed concentration of Givinostat. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=20 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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Tmax of Givinostat, Following Single Doses of the Parent Drug
|
2.00 hours
Interval 1.0 to 4.0
|
1.50 hours
Interval 0.5 to 2.5
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—
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PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in each arm are n=19 and not n=20
λz is the apparent first order elimination rate constant associated with the terminal (log-linear) portion of the concentration versus time curve. The parameter is estimated by linear least square regression analysis using the last three (or more) non- zero concentrations. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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λz of Givinostat, Following Single Doses of the Parent Drug
|
0.112 1/hour
Geometric Coefficient of Variation 4.9
|
0.103 1/hour
Geometric Coefficient of Variation 23.2
|
—
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PRIMARY outcome
Timeframe: In the turn of 72 hours after administration of GivinostatPopulation: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. Please note that one of the 20 PK subjects early withdrew from the study before taking any study drug. This explains why patients analyzed in each arm are n=19 and not n=20.
t1/2 is the apparent terminal elimination half-life, calculated as ln(2)/λz. A total of 40 blood samples were collected as follows: \- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
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|---|---|---|---|
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t1/2 of Givinostat, Following Single Doses of the Parent Drug
|
6.18 hours
Geometric Coefficient of Variation 4.9
|
6.70 hours
Geometric Coefficient of Variation 23.0
|
—
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SECONDARY outcome
Timeframe: Throughout the study and 10-14 days after the EoS (follow-up visit), i.e. up to day 30-34Population: Pharmacokinetic Analysis Population: subjects enrolled in the study, who provided evaluable pharmacokinetic data for at least one IMP, without deviations affecting pharmacokinetic interpretation. For one of the 20 PK subjects, though, data at day 8 are missing.
An AE was considered as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily imply a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The period of observation for the collection of medical occurrences extended from the time when the subject gave Informed Consent until the follow-up visit.
Outcome measures
| Measure |
Givinostat Alone (Day 1)
n=20 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, alone, on Day 1.
|
Givinostat Co-Administered With Clarithromycin (Day 8)
n=19 Participants
Givinostat 10 mg/mL oral suspension was administered as a single dose, in combination with Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) on Day 8.
|
Total Enrolled
n=20 Participants
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
|
|---|---|---|---|
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Severity of Treatment Emergent Adverse Events (TEAE)
mild
|
43 number of events
|
41 number of events
|
43 number of events
|
|
Severity of Treatment Emergent Adverse Events (TEAE)
moderate
|
3 number of events
|
0 number of events
|
3 number of events
|
|
Severity of Treatment Emergent Adverse Events (TEAE)
severe
|
0 number of events
|
0 number of events
|
0 number of events
|
|
Severity of Treatment Emergent Adverse Events (TEAE)
total
|
46 number of events
|
41 number of events
|
46 number of events
|
Adverse Events
Givinostat
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Clarithromycin
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Total Enrolled
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Givinostat
n=20 participants at risk
givinostat 50 mg as oral suspension was administered as a single dose, on Days 1 and 8
|
Clarithromycin
n=19 participants at risk；n=20 participants at risk
Clarithromycin 500 mg immediate-release film-coated tablets (Klacid®) b.i.d. Days 4-7, 9-10
|
Total Enrolled
n=20 participants at risk
Givinostat 50 mg Day 1 Clarithromycin 500 mg b.i.d. Days 4-7 Clarithromycin 500 mg b.i.d + Givinostat 50 mg Day 8 Clarithromycin 500 mg b.i.d. Days 9-10
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
21.1%
4/19 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
20.0%
4/20 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.5%
2/19 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
4/20 • Number of events 4 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
21.1%
4/19 • Number of events 4 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
20.0%
4/20 • Number of events 4 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
General disorders
Vessel puncture site haemorrhage
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Investigations
Blood thyroid stimulating hormone increased
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.5%
2/19 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
0.00%
0/19 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
21.1%
4/19 • Number of events 5 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
20.0%
4/20 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Nervous system disorders
Migraine
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.5%
2/19 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
10.0%
2/20 • Number of events 2 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
40.0%
8/20 • Number of events 8 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
36.8%
7/19 • Number of events 7 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
40.0%
8/20 • Number of events 8 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.3%
1/19 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
5.0%
1/20 • Number of events 1 • Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected.
End-of-study was defined as the last study procedure on Day 11 or at early discontinuation of subjects administered at least one dose of investigational product. Early termination procedures were performed as soon as possible after subject withdrawal, within 10-14 days after last participation of the subject in the study, whenever possible
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place